Patologia: Neoplasie cerebrali, Altre neoplasie
Fase di studio: 1,
Richiesta mandatoria di tessuto: Sì
Linee di trattamento: Prima linea, Seconda linea
Criteri di inclusione:
- Histologically confirmed advanced solid tumors with measurable lesions per RECIST v1.1 or RANO for primary brain tumors that are considered nonamenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable per RECIST v1.1 if progression has been demonstrated in the lesion, active HBV or HCV infection that requires treatment
- Willingness to undergo a tumor biopsy to obtain tumor tissue,Pretreatment and on-treatment tumor biopsies are required.
- Must have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to or ineligible for standard treatment. There is no limit to the number of prior treatment regimens.
- Eastern Cooperative Oncology Group performance status score of 0 or 1.
- Life expectancy > 12 weeks.
Criteri di esclusione:
- Laboratory values not within the Protocol-defined range.
- Clinically significant cardiac disease.
- History or presence of an ECG that, in the investigator's opinion, is clinically meaningful.
- Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases that have progressed. Participants who have previously treated and clinically stable brain or CNS metastases and have not required steroids for at least 7 days before study treatment are eligible.
- Known additional malignancy that is progressing or requires active treatment.
- Has not recovered to ≤ Grade 1 or baseline from toxic effects of prior therapy and/or complications from prior surgical intervention before starting study treatment.
- Treatment with anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.
- Active infection requiring systemic therapy.
- Known history of HIV (HIV 1/2 antibodies).
- Known hypersensitivity or severe reaction to any component of study drug or formulation components.
- Prior receipt of an anti-PD-L1 therapy for all participants.
- Presence of a gastrointestinal condition that may affect drug absorption.
Trattamento di controllo:
IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Policlinico Le Scotte
Numero di iscrizione a registro: 2019-004377-27
Data di inserimento: 11.06.2021
Istituto Nazionale Tumori IRCCS 'Fondazione Pascale', Napoli
Riferimento: Dr. non disponibile